# K211436: Intermittent Catheter (Not Finalized)

- Pathway: 510(k) (Traditional)
- Applicant: Hollister Incorporated
- Decided: Jan 27, 2022 after 262 days
- Product code: GBM (Catheter, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910022 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163179: Onli Intermittent Catheter, Hollister Incorporated (2017) Summary page 4.

## Recalls of this device
- Jul 14, 2026 · Class II · Z-2998-2026: Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

## Indications for use
The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

Source page: https://510kreport.com/device/K211436
Methodology: https://510kreport.com/methodology